A Randomized Trial to Reduce Inappropriate Prescribing to Older Adults Visiting the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change PIM prescribing rate
Study Overview
Brief Summary
Cluster-randomized trial assessing the impact of interventions on guideline-concordant prescribing in Emergency Departments (ED). The study compares the effectiveness of feedback messages about potentially inappropriate medications (PIMs) delivered by peer clinician prescribers or anonymous systems, compared to standard of care. The goal is to reduce PIM prescribing for older adults discharged from emergency departments.
Detailed Description
The goal of this trial is to compare the effectiveness of prescribing feedback delivered by a credible peer messenger and by an anonymous messaging system against standard of care in emergency departments. This intervention to Emergency Department (ED) clinician prescribers is a modification of previous studies that optimizes feedback about Potentially Inappropriate Medications (PIMs) using findings from behavioral science. Clinician prescribers who meet eligibility criteria and provide digital affirmative consent will be enrolled if they have encounters in a participating ED facility. The Joint Data Analytics Team (JDAT) will identify patients aged 65 years and older who were seen in the ED to evaluate prescribing outcomes. The focus of this registration is the randomized trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Licensed clinicians with prescribing authority (physician, advanced practice registered nurse, or physician assistant)
- Practicing in one of the participating Yale New Haven Health System emergency departments
- At least 30 Emergency Department (ED) discharge encounters with patients aged 65 years or older in the 12 months preceding study enrollment
- Provides digital affirmative consent to participate
Exclusion Criteria
- Failure to meet inclusion criteria
Arms & Interventions
Control group
Providers continue with standard of care. No feedback messages are sent.
Credible Peer Messenger
Providers receive automated prescribing feedback messages from a credible peer messenger, including aspirational norms and benchmark comparisons based on Geriatric Emergency Medication Safety Recommendations (GEMS-Rx) recommendations, to promote safer prescribing practices.
Intervention: Prescribing Feedback (Behavioral)
Anonymous Messenger
Providers receive automated prescribing feedback messages from an anonymous messenger system, including aspirational norms and benchmark comparisons based on Geriatric Emergency Medication Safety Recommendations (GEMS-Rx) recommendations, to promote safer prescribing practices.
Intervention: Prescribing Feedback (Behavioral)
Outcomes
Primary Outcomes
Change PIM prescribing rate
Time Frame: At ED discharge, calculated monthly, using rolling 90-day prescribing data, over the 12-month intervention period and 6-month follow-up
Change in potentially inappropriate medication (PIM) prescribing rate based on the Geriatric Emergency Medication Safety Recommendations (GEMS-Rx). Outcome is measured as the percentage of Emergency Department (ED) discharge prescriptions for PIMs among patients aged 65 years or older.
Secondary Outcomes
- Changes in prescribing by medication class(At ED discharge, calculated monthly, using rolling 90-day prescribing data, over the 12-month intervention period and 6-month follow-up)
- Adoption of alternative recommendations(Monthly during the 12-month intervention period and 6-month follow-up)
- Access to Epic workbench reports(Monthly during the 12-month intervention period and 6-month follow-up)
- Mean overall readmission rate(Measured at 30 days post-discharge for all eligible ED visits during the 12-month intervention period and 6-month follow-up)
- Changes in prescribing by medication class(At ED discharge, calculated monthly, using rolling 90-day prescribing data, over the 12-month intervention period and 6-month follow-up)
- Adoption of alternative recommendations(Monthly during the 12-month intervention period and 6-month follow-up)
- Access to Epic workbench reports(Monthly during the 12-month intervention period and 6-month follow-up)
- Mean overall readmission rate(Measured at 30 days post-discharge for all eligible ED visits during the 12-month intervention period and 6-month follow-up)
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT07146763
- Other Study IDs
- 2000036876, P30AG024968
Dates
- First Submitted
- (last year)
- First Posted
- (last year)
- Primary Completion
- (next year)
- Study Completion
- (next year)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
De-identified data will be transferred to the National Archive for Computerized Data On Aging (NACDA)